Meeting the Needs of FDA UDI Compliance

Learn how your company can support UDI requirements with GS1 Standards

The FDA UDI rule on the establishment of a Unique Device Identification System requires that medical devices distributed in the U.S. must now carry a Unique Device Identifier (UDI), with some exceptions. This system will provide a standardized way to identify devices across all information sources and systems, including electronic health records and device registries.

Global GS1 Standards, administered in the U.S. by GS1 US®, are authorized for use by manufacturers to address requirements of the new FDA UDI regulation. As GS1 is an FDA-Accredited Issuing Agency, GS1 US can help your company address UDI requirements with proven product identification and barcoding standards used by over two million companies worldwide.

Gain a deeper understanding of the U.S. FDA Unique Device Identification Rule.

UDI and GTIN
The two parts of the FDA UDI include the Device Identifier (DI), which is specific to a device model, and a Production Identifier (PI), which includes the current production information for that specific device, such as the lot or batch number, the serial number, expiration date, and production date.

GS1 Global Trade Item Number® (GTIN®) and GS1 Application Identifiers (AIs) can be used for the DI (GTIN) and PI (AIs)

Product marking and GS1 barcodes
The UDI must appear on the label in a human-readable format, as well as in a manner that can be read by automatic identification and data capture (AIDC) technology, and on every level of packaging.

GS1 Linear and GS1 DataMatrix barcodes can be used for marking

FDA GUDID Database submissions and GDSN
Medical device manufacturers will need to submit a standard set of basic identifying data attributes to the FDA Global UDI Database (FDA GUDID) for each of their products.

The GS1 Global Data Synchronization Network™ (GDSN®), currently used by the industry to share standardized healthcare product information across supply chain partners, can also be used to populate the FDA GUDID

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